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Results Announced from Phase 3 Trial of Daclizumab High Yield Process in Relapsing MS

June 18, 2014

Results from a large-scale, Phase 3 trial suggested that Daclizumab high yield process (DAC HYP), an experimental immune-modulating therapy taken by injection every four weeks, reduced relapses and disease activity significantly more than Avonex® (interferon beta-1a, Biogen Idec) in people with relapsing MS over two to three years. The top-line results from the DECIDE study were announced by Biogen Idec and AbbVie in a press release dated June 16, 2014. More details are expected to be presented at a future medical conference.

Background: Daclizumab is a laboratory-created monoclonal antibody that targets a receptor (docking site) that helps a key immune signaling chemical, called interleukin-2, to activate immune T cells thought to be involved in MS attacks. A form of this medication is approved for use in organ transplant rejection. DAC HYP is a highly concentrated liquid formulation of Daclizumab. Results of previous phase 2 trials of Daclizumab and DAC HYP suggested potential benefits for reducing relapses or MRI-detected disease activity in people with relapsing MS.

The Study: During this trial, more than 1,800 participants with relapsing-remitting MS were randomly assigned to receive either DAC HYP injected under the skin every four weeks, or Avonex injected once weekly, for 96 to 144 weeks. Participants also received placebo versions of Avonex or DAC HYP as a control measure. The primary endpoint of the study was to determine DAC HYP’s effectiveness in reducing relapse rates. Secondary endpoints included disease activity as observed on MRI scans, and clinical measures such as the EDSS scale of disease activity. Additional endpoints included safety, tolerability, and quality of life.

According to the press release, the primary endpoint was met, with DAC HYP significantly reducing the relapse rate more than Avonex. DAC HYP also reduced disease activity observed on MRI scans significantly more than Avonex.

Serious infections occurred more often in the group taking DAC HYP, as did elevated liver enzymes. There were 4 deaths in the IFN β-1a group and 1 death in the DAC HYP group, none of which was considered to be related to the treatments, according to the release.

Next Steps: The companies plan to work with regulatory agencies to determine appropriate timelines for filing for marketing approval, and plan to present detailed results at a future medical conference.

“We look forward to seeing the complete results of this study to more fully understand the potential benefits and safety of Daclizumab high yield process for treating MS,” says Timothy Coetzee, PhD, Chief, Advocacy, Services and Research Officer of the National MS Society.

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.